Licensing & Approvals: Obtain product permissions from relevant regulatory authorities. Prepare and submit applications for new manufacturing licenses. Liaise with government agencies to ensure timely approvals and renewals Dossier Compilation: Compile, review, and submit regulatory dossiers in CTD (Common Technical Document) and ACTD (ASEAN Common Technical Document) formats. Ensure documentation complies with national and international regulatory standards. Coordinate with internal departments to gather required technical and quality data. Artwork Compliance: Review product artwork and labeling to ensure alignment with regulatory standards and country-specific requirements. Provide feedback and corrections to design teams to maintain compliance. Qualifications & Skills: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field. 2–5 years of experience in regulatory affairs within the pharmaceutical or healthcare industry. Strong understanding of regulatory guidelines (e.g., CDSCO, ASEAN). Proficiency in dossier preparation and submission processes. Excellent communication and documentation skills. Job Types: Full-time, Permanent Pay: ₹180,000.00 - ₹360,000.00 per year Benefits: Health insurance Work Location: In person
Licensing & Approvals: Obtain product permissions from relevant regulatory authorities. Prepare and submit applications for new manufacturing licenses. Liaise with government agencies to ensure timely approvals and renewals Dossier Compilation: Compile, review, and submit regulatory dossiers in CTD (Common Technical Document) and ACTD (ASEAN Common Technical Document) formats. Ensure documentation complies with national and international regulatory standards. Coordinate with internal departments to gather required technical and quality data. Artwork Compliance: Review product artwork and labeling to ensure alignment with regulatory standards and country-specific requirements. Provide feedback and corrections to design teams to maintain compliance. Qualifications & Skills: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field. 2–5 years of experience in regulatory affairs within the pharmaceutical or healthcare industry. Strong understanding of regulatory guidelines (e.g., CDSCO, ASEAN). Proficiency in dossier preparation and submission processes. Excellent communication and documentation skills. Job Types: Full-time, Permanent Pay: ₹180,000.00 - ₹360,000.00 per year Benefits: Health insurance Work Location: In person